HysterectomyNCT06473675
Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System (The HYPER Study)
An observational study of Hysterectomy, run by Distalmotion SA at 4 sites in 2 countries.
Trial summary
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Hysterectomy with adnexal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 20 Jun 2024to 2 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing a hysterectomy with adnexal surgery for benign disease.
Who may be able to join
- Aged > 18 years
- Patients planned to undergo elective robot-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease; using one camera port, two ports for the manipulating instruments, and additional ports as needed.
Who cannot join
- Morbidly obese patients (BMI > 40)
- Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
- Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
- Bleeding diathesis
- Pregnancy
- Patients with pacemakers or internal defibrillators
Show all 9Show fewer
- Any planned concomitant procedures
- Patient deprived of liberty by administrative or judicial decision.
- Participation in another interventional clinical trial
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Switzerland3 sites
Kantonsspital Baden
Baden
Inselspital Bern
Bern
Spitäler FMI AG
Interlaken
About this study
Official title: Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.
- Conditions
- Hysterectomy
- Being tested
- Hysterectomy with adnexal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysterectomy with adnexal surgeryProcedure or surgery
Robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.
What is being measured
The primary outcome is the main question the study is designed to answer.
primary safety endpoint
occurrence of Clavien - Dindo grades III-V adverse events
Measured: up to 42 days
primary performance endpoint
successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start20 Jun 2024
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Distalmotion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Confinis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473675
- Sponsor's protocol ID
- 2024-01
- Status last verified
- Apr 2026
- First submitted
- 19 Jun 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gulz M, Bodet ML, Streich M, Habegger A, Heubner M, Erhardt D, Bogdanovic B, Mueller MD. Multicenter evaluation of the DEXTER(R) Robotic Surgery System for Total Hysterectomy with Adnexal Surgery. J Robot Surg. 2025 Sep 26;19(1):634. doi: 10.1007/s11701-025-02647-0.
PubMed 40999110
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System
- ClinicalTrials.gov ID
- NCT06473675
- Acronym / sponsor ID
- 2024-01
- Conditions
- Hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Distalmotion SAIndustry (pharma, biotech, devices)
- Collaborators
- Confinis
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing a hysterectomy with adnexal surgery for benign disease.
Key inclusion criteria (2 listed)
- Aged > 18 years
- Patients planned to undergo elective robot-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease; using one camera port, two ports for the manipulating instruments, and additional ports as needed.
Key exclusion criteria (9 listed)
- Morbidly obese patients (BMI > 40)
- Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
- Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
- Bleeding diathesis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysterectomy with adnexal surgeryRobotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease. | Procedure or surgery | – |
Primary outcome
primary safety endpoint
Time frame: up to 42 days
occurrence of Clavien - Dindo grades III-V adverse events
primary performance endpoint
Time frame: intraoperative
successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 40999110Gulz M, Bodet ML, Streich M, Habegger A, Heubner M, Erhardt D, Bogdanovic B, Mueller MD. Multicenter evaluation of the DEXTER(R) Robotic Surgery System for Total Hysterectomy with Adnexal Surgery. J Robot Surg. 2025 Sep 26;19(1):634. doi: 10.1007/s11701-025-02647-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hysterectomy, run by Distalmotion SA at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary safety endpoint (time frame: up to 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.